Purpose & Rationale of the Clinical Component of the Administrative Core: Case Western Reserve University (CWRU) School of Medicine is one of the leading research universities in the United States, and currently ranks among the top 25 research institutions in terms of NIH funding. Currently, CWRU is the recipient the Case Comprehensive Cancer Center, one of only 40 NCI-designated comprehensive cancer centers in the United States, and a Clinical and Translational Science Collaborative (CTSC) Award, in collaboration with the Cleveland Clinic Foundation (CCF). The University and its affiliated teaching hospitals have made strong financial commitments to building clinical and translational research through targeted faculty recruitment and resource allocation. Building on these strategic priorities, the Clinical Component of the Cleveland Digestive Diseases Research Core Center (DDRCC) provides access to: 1) reduced rates for DDRCC members to biostatistical consultations, 2) clinical protocol development, and 3) clinical and administrative databases and measurement tools. This DDRCC Clinical Component will greatly facilitate high quality experimental design and analysis, encourage basic research investigators to conduct translational and patient-oriented research studies related to digestive diseases, and facilitate the design and implementation of high-quality clinical studies related to the epidemiology and treatment of digestive disease by physician scientists and clinical investigators alike. The objectives of the Clinical Component are to greatly improve the quality of scientific findings resulting from DDRCC supported projects and to create a conduit for translating basic research into the clinical setting by providing access to experienced biostatisticians and health services and outcomes researchers. The biostatistical services of the proposed Clinical Component will include assistance in preparation of relevant sections of grant proposals and manuscripts, power and sample size calculations, and univariate and multivariate data analysis. The protocol development services will include assistance with approaches to study design, development of appropriate measures including quantitative and qualitative instruments, and access to secondary data sources that are housed at CWRU. These resources will be invaluable to DDRCC members as they translate their research findings from the bench to the bedside.